Effectiveness and safety of dupilumab for the treatment of severe asthma in a real‐life French multi‐centre adult cohort

Autor: Laurent Guilleminault, Lise Rosencher, A. Proust, Arnaud Bourdin, Clairelyne Dupin, S. Fry, Drifa Belhadi, Cécile Chenivesse, Patrick Berger, Frédéric de Blay, Alain Didier, Anne‐Sophie Gamez, Camille Couffignal, Philippe Bonniaud, Gilles Garcia, Camille Taillé, Pierre-Olivier Girodet, Chantal Raherison, Christophe Leroyer, Geneviève Le Bourdellès, Guillaume Mahay
Přispěvatelé: MORNET, Dominique, Physiopathologie et Epidémiologie des Maladies Respiratoires (PHERE (UMR_S_1152 / U1152)), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université Paris Cité (UPCité), AP-HP - Hôpital Bichat - Claude Bernard [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Département d'épidémiologie, biostatistique et recherche clinique, Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-AP-HP - Hôpital Bichat - Claude Bernard [Paris], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Centre de Physiopathologie Toulouse Purpan (CPTP), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Centre de recherche Cardio-Thoracique de Bordeaux [Bordeaux] (CRCTB), Université Bordeaux Segalen - Bordeaux 2-CHU Bordeaux [Bordeaux]-Institut National de la Santé et de la Recherche Médicale (INSERM), CHU Strasbourg, Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Département de Médecine Interne et Pneumologie [Brest] (DMIP - Brest), Centre Hospitalier Régional Universitaire de Brest (CHRU Brest), Université européenne de Bretagne - European University of Brittany (UEB), CHU Rouen, Normandie Université (NU), Université de Bordeaux (UB), Centre d'Investigation Clinique - Epidemiologie Clinique / Essais Cliniques Bordeaux, Institut National de la Santé et de la Recherche Médicale (INSERM), Bordeaux population health (BPH), Université de Bordeaux (UB)-Institut de Santé Publique, d'Épidémiologie et de Développement (ISPED)-Institut National de la Santé et de la Recherche Médicale (INSERM), Institut Pasteur de Lille, Réseau International des Instituts Pasteur (RIIP), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Service de pneumologie [Hôpital Foch], Hôpital Foch [Suresnes], Centre Hospitalier Universitaire de Nîmes (CHU Nîmes), CHU Tenon [AP-HP], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Sorbonne Université (SU), Université Paris-Sud - Paris 11 (UP11), Université Paris-Saclay, Hôpital Bicêtre, Centre Hospitalier Régional Universitaire [Montpellier] (CHRU Montpellier), Physiologie & médecine expérimentale du Cœur et des Muscles [U 1046] (PhyMedExp), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Montpellier (UM)-Centre National de la Recherche Scientifique (CNRS), Service Pneumologie et allergologie pédiatrique [CHU Toulouse], Pôle Enfants [CHU Toulouse], Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Paris (UP), Centre d'Investigation Clinique – Épidémiologie Clinique [Paris], Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Institut National de la Santé et de la Recherche Médicale (INSERM), Hôpital Purpan [Toulouse], CHU Toulouse [Toulouse], Université de Bourgogne (UB)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale (INSERM), Sorbonne Université (SU)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP), Université de Montpellier (UM)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Service de pneumologie et allergologie pédiatrique [CHU Toulouse]
Rok vydání: 2020
Předmět:
Male
0301 basic medicine
Hypereosinophilia
Severity of Illness Index
[SDV.MHEP.PSR]Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract
0302 clinical medicine
Prednisone
Interquartile range
Immunology and Allergy
[SDV.IMM.ALL]Life Sciences [q-bio]/Immunology/Allergology
oral steroid
MESH: Antibodies
Monoclonal
Humanized / adverse effects
MESH: Middle Aged
EPICENE
MESH: Follow-Up Studies
Middle Aged
Dupilumab
3. Good health
Cohort
Female
France
[SDV.IMM.IMM] Life Sciences [q-bio]/Immunology/Immunotherapy
medicine.symptom
[SDV.IMM.ALL] Life Sciences [q-bio]/Immunology/Allergology
Cohort study
medicine.drug
Adult
medicine.medical_specialty
Immunology
Antibodies
Monoclonal
Humanized
03 medical and health sciences
T2 inflammation
MESH: Severity of Illness Index
Internal medicine
side‐effect
medicine
Humans
MESH: Asthma / physiopathology
hypereosinophilia
MESH: Antibodies
Monoclonal
Humanized / administration & dosage
Retrospective Studies
Asthma
MESH: Humans
business.industry
MESH: Adult
MESH: Retrospective Studies
Retrospective cohort study
MESH: Asthma / drug therapy
[SDV.IMM.IMM]Life Sciences [q-bio]/Immunology/Immunotherapy
asthma
medicine.disease
MESH: Male
MESH: France
030104 developmental biology
030228 respiratory system
[SDV.MHEP.PSR] Life Sciences [q-bio]/Human health and pathology/Pulmonology and respiratory tract
MESH: Asthma / blood
business
MESH: Female
Follow-Up Studies
Zdroj: Clinical and Experimental Allergy
Clinical and Experimental Allergy, 2020, 50 (7), pp.789-798. ⟨10.1111/cea.13614⟩
Clinical and Experimental Allergy, Wiley, 2020, 50 (7), pp.789-798. ⟨10.1111/cea.13614⟩
ISSN: 1365-2222
0954-7894
DOI: 10.1111/cea.13614
Popis: International audience; Background: Dupilumab is a monoclonal anti‐IL‐4Rα antibody developed for the treatment of severe asthma (SA). An early access programme for dupilumab was opened in France in SA patients experiencing unacceptable steroids side‐effects and/or life‐threatening exacerbations.Objective: To assess changes in asthma control between baseline and 12 months of treatment.Methods: Multi‐centre (n = 13) retrospective real‐life cohort study. This study is registered on ClinicalTrials.gov (NCT04022447).Results: Overall, 64 patients with SA (median age 51, interquartile range [44‐61]; 53% females) received dupilumab as add‐on therapy to maximal standard of care; and 76% were on oral daily steroids at baseline. After 12 months, median asthma control test score improved from 14 [7‐16] to 22 [17‐24] (P < .001); median forced expiratory volume in 1 seconds increased from 58% [47‐75] to 68% [58‐88] (P = .001); and daily prednisone dose was reduced from 20 [10‐30] to 5 [0‐7] mg/d (P < .001). Annual exacerbations decreased from 4 [2‐7] to 1 [0‐2] (P < .001). Hypereosinophilia ≥1500/mm3 was observed at least once during follow‐up in 16 patients (25%), persisting after 6 months in 8 (14%) of them. Increase in blood eosinophil count did not modify the clinical response during the study period. Injection‐site reaction was the most common side effect (14%). Three deaths were observed, none related to treatment by investigators.Conclusion & clinical relevance: In this first real‐life cohort study of predominantly steroid‐dependent SA, dupilumab significantly improved asthma control and lung function and reduced oral steroids use and exacerbations rate. Despite limitations due to the retrospective study, these results are consistent with controlled trials efficacy data. Further studies are required to assess the clinical significance and long‐term prognosis of sustained dupilumab‐induced hypereosinophilia.
Databáze: OpenAIRE
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